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BioGenes Is Your Partner for Routine and Sophisticated Projects

Read our latest article about reliable HCP Detection

The clearance of biopharmaceutical drugs from host cell protein (HCP) impurities during manufacturing remains a constant challenge, necessitating the reliable monitoring of their removal from the final drug product. To ensure high-level patient safety during clinical trials and upon drug product release, a multitude of regulations have been authored by different regulatory bodies, such as the US FDA and the EMA.

In our latest article, published in the European Biopharmaceutical Review magazine (January 2021), the authors Dr. Martin Foege and Stefan Sommerschuh elaborate on the critical steps in developing custom HCP ELISAs and how to address them.

Read the Article today!